CARES Act Updates

Summary

On February 8, 2024, the U.S. Department of Health & Human Services (HHS) through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights announced a final rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”). With this final rule, HHS is implementing the confidentiality provisions of section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act - PDF (enacted March 27, 2020), which require the Department to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health Act (HITECH).

Major Changes in the New Part 2 Rule

The final rule includes the following modifications to Part 2:

  • Patient Consent
    • Allows a single consent for all future uses and disclosures for treatment, payment, and health care operations.
    • Allows HIPAA covered entities and business associates that receive records under this consent to redisclose the records in accordance with the HIPAA regulations.1
  • Other Uses and Disclosures
    • Permits disclosure of records without patient consent to public health authorities, provided that the records disclosed are de-identified according to the standards established in the HIPAA Privacy Rule.
    • Restricts the use of records and testimony in civil, criminal, administrative, and legislative proceedings against patients, absent patient consent or a court order.
  • Penalties: Aligns Part 2 penalties with HIPAA by replacing criminal penalties currently in Part 2 with civil and criminal enforcement authorities that also apply to HIPAA violations.2
  • Breach Notification: Applies the same requirements of the HIPAA Breach Notification Rule3 to breaches of records under Part 2.
  • Patient Notice: Aligns Part 2 Patient Notice requirements with the requirements of the HIPAA Notice of Privacy Practices.
  • Safe Harbor: Creates a limit on civil or criminal liability for investigative agencies that act with reasonable diligence to determine whether a provider is subject to Part 2 before making a demand for records in the course of an investigation. The safe harbor requires investigative agencies to take certain steps in the event they discover they received Part 2 records without having first obtained the requisite court order.
  • Safe Harbor: Clarifies and strengthens the reasonable diligence steps that investigative agencies must follow to be eligible for the safe harbor: before requesting records, an investigative agency must look for a provider in SAMHSA’s online treatment facility locator and check a provider’s Patient Notice or HIPAA Notice of Privacy Practices to determine whether the provider is subject to Part 2.
  • Segregation of Part 2 Data: Adds an express statement that segregating or segmenting Part 2 records is not required.
  • Complaints: Adds a right to file a complaint directly with the Secretary for an alleged violation of Part 2. Patients may also concurrently file a complaint with the Part 2 program.
  • SUD Counseling Notes: Creates a new definition for an SUD clinician’s notes analyzing the conversation in an SUD counseling session that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record and that require specific consent from an individual and cannot be used or disclosed based on a broad TPO consent. This is analogous to protections in HIPAA for psychotherapy notes.4
  • Patient Consent:
    • Prohibits combining patient consent for the use and disclosure of records for civil, criminal, administrative, or legislative proceedings with patient consent for any other use or disclosure.
    • Requires a separate patient consent for the use and disclosure of SUD counseling notes.
    • Requires that each disclosure made with patient consent include a copy of the consent or a clear explanation of the scope of the consent.
  • Fundraising: Create a new right for patients to opt out of receiving fundraising communications.